Two-stage design and 'forced bioequivalence' [Two-Stage / GS Designs]

posted by Mikalai  – Belarus, 2018-06-06 10:28 (2122 d 22:00 ago) – Posting: # 18854
Views: 5,566

Dear all,
We plan to conduct a sequential (two stage) BE study, and I am concerned with "forced bioequivalence". Specifically, if we obtain non-equivalent results in the first stage with very low power and should recruit more volunteers, how can we protect ourselves from getting into "forced bioequivalence"? In other words, how can we differentiate between underpowered trials and non-equivalent results in the sequential BE? And how can we put this (protection against "forced bioequivalence") in the protocol not to raise many questions from regulators?
Any suggestions and advice will be appreciated.
Sincerely,
Mikalai

Complete thread:

UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
105 visitors (0 registered, 105 guests [including 7 identified bots]).
Forum time: 07:29 CET (Europe/Vienna)

With four parameters I can fit an elephant,
and with five I can make him wiggle his trunk.    John von Neumann

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5